Surgical devices

ABSTRACT

The present disclosure relates to a surgical device including a shaft having an outer member and an inner member slidably received within the outer member, a handle coupled to the shaft, and a combination of a cannulated body having a distal end and a proximal end, a plug including a top portion configured for engagement with the proximal end of the body and a bottom portion coupled to the top portion, a first portion disposed on the bottom portion of the plug, a second portion disposed on the bottom portion of the plug, and a spring located between the first and second portions for providing movement to the inner member coupled to the inner member. A method of tissue repair is also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Patent Application No.61/081,462 filed on Jul. 17, 2008, the disclosure of which isincorporated herein by reference in its entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical devices for use in tissuerepair.

2. Related Art

Arthroscopic procedures often require soft tissue to be reattached tobone. To achieve this, anchors are placed in the bone and suturesattached to the anchor are passed through the tissue to securely retainthe tissue in place. When making a repair of soft tissue to bone, it isadvantageous to have as large an area of contact between the bone andtissue as possible. Anchor points spaced from one another in rows resultin a repair having a broader area of contact. A procedure, and devicesfor use in such procedure, that securely attaches tissue to bone using aplurality of attachment points over a large area of contact is needed.

SUMMARY

The present disclosure relates to a surgical device including; a shafthaving an outer member and an inner member slidably received within theouter member, a handle coupled to the shaft, and a means for providingmovement to the inner member coupled to the inner member. In anembodiment, the surgical device further comprises an anchor assemblycoupled to the device, wherein the anchor assembly comprises an anchordefining a cavity and an insertion member housed within the cavity. Inanother embodiment, the outer member includes a distal portionconfigured to engage the anchor and the inner member includes a distalportion configured to engage the insertion member. In yet anotherembodiment, the surgical device further comprises a suture threadercoupled to the shaft, wherein the threader includes a clip and a loop ofsuture coupled to the clip. In a further embodiment, the loop of sutureis disposed within a transverse through hole extending through theanchor.

In a further embodiment, the means for providing movement to the innermember includes a cannulated body having a distal end and a proximalend, a plug including a top portion configured for engagement with theproximal end of the body and a bottom portion coupled to the topportion, a first portion disposed on the bottom portion of the plug, asecond portion disposed on the bottom portion of the plug, and a springlocated between the first and second portions. In yet a furtherembodiment, the proximal end of the body includes gears. In anembodiment, the first portion includes gears configured for engagementwith the gears of the proximal end of the body. In another embodiment,the outer member is shorter than the inner member.

In another aspect, the present disclosure relates to a method of tissuerepair including inserting a first anchor into bone, the first anchorhaving a flexible member coupled thereto; passing ends of the flexiblemember through the tissue; providing a surgical device including a shafthaving an outer member and an inner member slidably received within theouter member, a handle coupled to the shaft, a means for providingmovement to the inner member coupled to the inner member, and an anchorassembly coupled to the shaft, the anchor assembly comprising an anchordefining a cavity and a transverse through hole and an insertion memberhoused within the cavity; passing at least one end of the flexiblemember through the through hole of the anchor assembly; placing theanchor assembly into bone; advancing the insertion member toward the atleast one end of the flexible member to secure the flexible member inthe through hole and the tissue to bone.

In an embodiment, the method further includes tensioning the flexiblemember before advancement of the insertion member. In anotherembodiment, advancement of the insertion member includes rotation of themeans for providing movement to the inner member. The means includes acannulated body having a distal end and a proximal end, a plug includinga top portion configured for engagement with the proximal end of thebody and a bottom portion coupled to the top portion, a first portiondisposed on the bottom portion of the plug, a second portion disposed onthe bottom portion of the plug, and a spring located between the firstand second portions. In yet another embodiment, the proximal end of thebody includes gears. In a further embodiment, the first portion includesgears configured for engagement with the gears of the proximal end ofthe body, wherein the means is rotated to advance the insertion memberuntil the gears of the first portion and the gears of the proximal endare no longer in direct engagement.

In an embodiment, the method further includes providing a surgicaldevice having a shaft including an outer member and an inner memberslidably received within the outer member, a handle coupled to theshaft, and a means for providing movement to the inner member coupled tothe inner member, wherein the outer member is shorter than the innermember; placing the surgical device into engagement with the anchorassembly such that the inner member is engaged with the insertion memberand the outer member is engaged with the anchor; moving the insertionmember away from the at least one end of the flexible member; tensioningthe flexible member; and advancing the insertion member back toward theflexible member to re-secure the flexible member.

In yet another embodiment, advancement of the insertion member towardthe flexible member includes rotation of the means for providingmovement to the inner member. The means includes a cannulated bodyhaving a distal end and a proximal end, a plug including a top portionconfigured for engagement with the proximal end of the body and a bottomportion coupled to the top portion, a first portion disposed on thebottom portion of the plug, a second portion disposed on the bottomportion of the plug, and a spring located between the first and secondportions. In a further embodiment, the proximal end of the body includesgears. In yet a further embodiment, the first portion includes gearsconfigured for engagement with the gears of the proximal end of thebody, wherein the means is rotated to advance the insertion member untilthe gears of the first portion and the gears of the proximal end are nolonger in direct engagement.

Further areas of applicability or the present disclosure will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples, whileindicating the preferred embodiment of the disclosure, are intended forpurposes of illustration only and are not intended to limit the scope ofthe disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and form a part ofthe specification, illustrate the embodiments of the present disclosureand together with the written description serve to explain theprinciples, characteristics, and features of the disclosure. In thedrawings:

FIG. 1 shows a perspective view of a first surgical device of thepresent disclosure.

FIG. 2 shows another perspective view of the surgical device of FIG. 1.

FIG. 3 shows a cross-sectional view of the handle of the surgical deviceof FIG. 1.

FIG. 4 shows a cross-sectional view of the means for providing movementof the inner member of the surgical device of FIG. 1.

FIG. 5 shows an exploded view of the means for providing movement of theinner member of FIG. 4.

FIG. 6 shows another exploded view of the means for providing movementof the inner member of FIG. 4.

FIG. 7 shows a perspective view of the distal portions of the inner andouter members of the surgical device of FIG. 1.

FIG. 8 shows a perspective view of the anchor assembly of the presentdisclosure.

FIG. 9 shows another perspective view of the anchor assembly of thepresent disclosure.

FIG. 10 shows a top view of the anchor assembly of the presentdisclosure.

FIG. 11 shows a perspective view of a second surgical device of thepresent disclosure.

FIG. 12 shows a cross-sectional view of the second surgical device ofFIG. 11.

FIG. 13 shows another perspective view of the second surgical device ofFIG. 11.

FIG. 14 shows a perspective view of the handle and means for providingmovement of the inner member of the second surgical device of FIG. 11.

FIGS. 15A-15D show use of the first surgical device of the presentdisclosure in repairing tissue.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The following description of the preferred embodiment(s) is merelyexemplary in nature and is in no way intended to limit the disclosure,its application, or uses.

FIGS. 1-3 show perspective views of the first surgical device 10 of thepresent disclosure. The device 10 includes a shaft 11 having an outermember 11 a and an inner member 11 b slidably received within the outermember 11 a. Coupled to the shaft 11 is a handle 12 having a body 12 awith grooves 12 b extending through the body 12 a and projections 12 clocated on the outer surface 12 d of the body 12 a. A means 13 forproviding movement to the inner member, as more clearly shown in FIGS.4-6 and as more fully explained below, is housed within an opening 12 eon the handle 12 and is coupled to a proximal portion 11 b′ of the innermember 11 b.

Also coupled to the shaft 11, specifically the distal portions 11 a″,11b″ (FIG. 7) of the outer and inner members 11 a,11 b), is an anchorassembly 14, as more clearly shown in FIGS. 8-10 and as more fullydescribed below. The distal portion 11 a″ of the outer member 11 aincludes a first laser mark 11 c, for purposes to be described later,and at least two divets 11 d for housing of suture, as will be morefully described below. A second laser mark 11 e extends a partial lengthof the outer member 11 a. At least two prongs 11 a′″ extendlongitudinally from the distal portion 11 a″ and are configured forengagement with the anchor of the anchor assembly 14, as will be furtherdescribed below. The divets 11 d are located at about 180° apart and arein line with grooves on the anchor assembly 14, as will be furtherdescribed below. The distal portion 11 b″ of the inner member 11 b alsoincludes at least two prongs 11 b′″ configured for engagement with theinsertion member of the anchor assembly 14, as will be further describedbelow.

A suture threader 15 is also releasably coupled to the shaft 11. Thethreader 15 includes a clip 15 a and a loop of suture 15 b coupled tothe clip 15 a. The suture loop 15 b is disposed within the transversethrough hole of the anchor assembly 14 and is used during surgery tothread ends of suture from another anchor into the through hole, asfurther described below.

As shown more clearly in FIGS. 3-6, the means 13 includes body 13 ahaving a distal end 13 a′ a proximal end 13 a″, wherein the distal end13 a′ is housed within the opening 12 e of the handle 12. The means 13also includes an inner cavity 13 b having a top portion 13 b′, a middleportion 13 b″, and a bottom portion 13 b′″. The top portion 13 b′ andthe middle portion 13 b″ are located in the proximal end 13 a″ and thebottom portion 13 b′″ is located between the proximal end 13 a″ and thedistal end 13 a′. The middle portion 13 b″ includes gears 13 c. Themeans 13 also includes a plug 13 d having a top end 13 d′ and a bottomend 13 d″. The top end 13 d′ is housed within the top portion 13 b′ ofthe cavity 13 b and the bottom end 13 d″ extends between the middleportion 13 b″ and bottom portion 13 b′″. The bottom portion 13 d′includes a channel 13 h for housing of the proximal portion 11 b of theinner member 11 and is configured for engagement with a first portion 13e and a second portion 13 f, as will be further described below.

A first portion 13 e is disposed on the bottom end 13 d″ of the plug 13d and includes gears 13 e′ that are configured for engagement with thegears 13 e on the middle portion 13 b″, as will be further describedbelow. A second portion 13 f is also disposed on the bottom end 13 d″ ofthe plug 13 d and includes a groove 13 f′ configured for receipt of aspring 13 g located between the first portion 13 e and the secondportion 13 f. The spring 13 g allows for the application of force on thefirst portion 13 e, thereby providing engagement of the gears 13 e′,13e.

FIGS. 8-10 show the anchor assembly 14 of the present disclosure. Theanchor assembly 14 includes an anchor 16 defining a cavity 16 a and aninsertion member 17 housed within the cavity 16 a. The anchor 16includes a proximal portion 16 b and a distal portion 16 c. The proximalportion 16 b includes at least two grooves 16 b′ for housing of theprongs 11 a′″ on the outer member 11 a. The insertion member 17 includesa head 17 a configured for engagement with the prongs 11 b′″ of theinner member 11 b. In addition, the anchor 16 includes a transversethrough hole 16 d and slots 16 e extending from openings 16 d′,16 d″ ofthe through hole 16 d to the proximal portion 16 b of the anchor 16, forpurposes to be described later. Other features of the anchor assemblyare described and shown in U.S. Patent Application Publication No.2009112270, the disclosure of which is incorporated herein by referencein its entirety.

FIGS. 11-14 show a second surgical device 20 of the present disclosure.Similar to the first surgical device 10, the device 20 includes a shaft21 having an outer member 21 a and an inner member 21 b slidablyreceived within the outer member 21 a. A handle 22 is coupled to theshaft 21 and a means 23 for providing movement to the inner member 21 b,similar to means 13 is coupled to a proximal portion 21 b′ of the innermember 21 b. The outer member 21 a is shorter than the inner member 21b, such that the distal portion 21 a″ of the outer member 21 a endsproximal to the distal portion 21 b″ of the inner member 21 b, as shownmore clearly in FIGS. 11 and 12. The prongs 24, divets 25, and lasermarks 26 of the outer member 21 a are all the same as the prongs 11 b,divets 11 d, and laser marks 11 e of the outer member 11 a of the firstsurgical device 10. Similarly, the prongs 27 of the inner member 21 bare the same as the prongs 11 b′″ of the inner member 11 b of the device10. In addition, the means 23 is the same as the means 13 of the device10.

During surgery, the first surgical device 10 is used to place the anchorassembly 14 into bone. FIGS. 15A-15C show the first surgical device 10in use during arthroscopic repair of the rotator cuff. FIG. 15A shows afirst anchor 30 that has been inserted into the lateral aspect of a bone40, such as a humeral bone. The anchor 30, which has a flexible member50, such as a suture, coupled thereto is inserted into the bone 40, asoft tissue 60, such as a rotator cuff tendon, is placed oil the bone 40to be located adjacent to the anchor 30, and at least one of the ends 51of the flexible member 50 are placed through the soft tissue 60.

Next at least one end 51 of the flexible member 50 is passed through theloop 15 b, as shown in FIG. 15A, and threaded through the transversethrough hole 16 d by pulling the loop 15 b and the flexible member 50through the transverse through hole 16 d, as shown in FIG. 15B, via useof the clip 15 a. After the flexible member 50 is passed through thethrough hole 16 d, the suture threader 15 is discarded. The anchorassembly 14 is subsequently inserted into a previously drilled hole 41in the medial aspect of the bone 40, as shown in FIG. 15C, such that theflexible member 50 is housed within the transverse through hole 16 d andthe ends 51 extend out of the hole 41. The anchor assembly 14 isadvanced into the hole 41 in an axially-oriented manner by tapping onthe means 13. As mentioned above, the first and second laser marks 11 c,11 e are used for proper orientation and depth of the anchor 16 into thehole 41. Namely, the anchor 16 is placed within the hole 41 such thatthe first laser mark 11 c is flush with the surface of the bone 40 andthe second laser mark 11 e allows for proper visual orientation of theanchor 16 while placing it in the bone 40.

After placement of the anchor assembly 14 into the hole 41, the ends 51of the flexible member 50 may be pulled to provide a preferred amount oftension on the flexible member 50 and the soft tissue 60. This tensionon the flexible member 50 can be seen in FIG. 15D, especially whencomparing this figure to FIG. 15C. The insertion member 17 issubsequently advanced in a rotary manner, via the inner member 11 b, tosecure the flexible member 50 in the through hole 16 d and the tissue 60to the bone 40. For clarity purposes, the insertion member 17 is notshown in FIGS. 15C and 15D. The anchor assembly 14 is located on thedistal portions 11 a″,11 b″ of the inner and outer members 11 a,11 bsuch that the slots 16 c are in-line with the divets 11 d, therebyallowing the flexible member 50 to slide and substantially reducing themember 50 from being caught between the distal portion 11 a″ and thehole 41.

By rotating the means 13, the inner member 11 a is rotated. Upon initialrotation of the means 13, the gears 13 c,13 e′ are in full engagementwith each other. However, once the insertion member 17 is engaged withthe flexible member 50 and the flexible member 50 is secured in thethrough hole 16 d, further rotation of the means 13 will cause downwardmovement of the first portion 13 e toward the second portion 13 f,thereby causing the gears 13 c′ to fall out of full engagement with thegears 13 c of the inner cavity 13 b. Further rotation of the means 13will cause the gears 13 c of the inner cavity 13 b to slide over thegears 13 e′ of the first portion 13 e, thereby not allowing furtherrotation of the insertion member 17. Not only is the means 13 used toprovide movement of the inner member, but it is also used to limit theamount of torque that is applied to the insertion member 17.

After placement of the anchor assembly 14, the second surgical device 20may be used to re-tension the flexible member 50. The device 20 isinserted into the anchor assembly 14 such that the prongs 27 on thedistal portion 21 b″ of the inner member 21 b are engaged with the head17 a of the insertion member 17. The handle 22 is then used to slide theouter member 21 a, as shown more clearly in FIGS. 13 and 14, toward theanchor assembly 14 and insert the prongs 24 into the grooves 16 b′ ofthe anchor 16. Once the inner and outer members 21 b,21 a are insertedinto the anchor assembly 14, the means 23 is rotated to disengage theinsertion member 17 from the flexible member 50. The flexible member 50is then re-tensioned and the means 23 is subsequently rotated to advancethe insertion member 17 and re-secure the flexible member 50 in thethrough hole 16 d, as described above. The first surgical device 10 maybe used to re-tension the flexible member 50, rather than the secondsurgical device 20.

The shafts 11,21 of the first and second surgical devices 10,20 includea stainless steel material, but may be made from any other metal ornon-metal material that is bio-compatible and strong enough to withstandthe forces that are placed on the shafts 11,21 during surgery. Theshafts 11,21 may be machined, die drawn and subsequently machined, ormade by any other method known to one of skill in the art. The shafts11,21 are coupled to the handles 12,22 and knobs 13,23 via a press-fitprocedure. However, other methods of coupling the handles 12,22 andknobs 13,23 to the shafts 11,21 are also within the scope of thisdisclosure. The handles 12,22 and knobs 13,23 are of a non-metalmaterial, but may be made from a metal material, and both are made viaan injection molding process. However, other methods of making are alsowithin the scope of this disclosure.

The clip 15 a is made from a non-metal material and is injection molded.However, other material, including metal materials, and processes arewithin the scope of this disclosure. The suture loop 15 b is coupled tothe clip 15 a via placing a first end of the loop 15 b through a hole inthe clip 15 a and then tying that end to a second end of the loop 15 b,as shown in FIG. 2. Other methods of coupling the suture loop 15 b tothe clip 15 a are also within the scope of this disclosure. In addition,other devices and methods of threading ends of suture from a previouslyplaced anchor through the transverse through hole 16 d are also withinthe scope of this disclosure.

The spring 13 g is of a metal material, but may be of a non-metalmaterial. In addition, other means of providing force resistance, otherthan the spring 13 g, may also be used. The divets 11 d are made via amachining process or other process known to one of skill in the art formaking markings, such as the divets 11 d, on the shafts 11,21.

As various modifications could be made to the exemplary embodiments, asdescribed above with reference to the corresponding illustrations,without departing from the scope of the disclosure, it is intended thatall matter contained in the foregoing description and shown in theaccompanying drawings shall be interpreted as illustrative rather thanlimiting. Thus, the breadth and scope of the present disclosure shouldnot be limited by any of the above-described exemplary embodiments, butshould be defined only in accordance with the following claims appendedhereto and their equivalents.

What is claimed is:
 1. A surgical system comprising: a shaft includingan outer member and an inner member slidably received within the outermember, the outer member including prongs extending from a distalportion of the outer member and the inner member including prongsextending from a distal portion of the inner member, the inner memberincluding a solid core extending from the distal end of the inner memberto a proximal end of the inner member; a handle coupled to the outermember; a means for providing movement to the inner member coupled tothe inner member and housed within an opening in the handle, the meansincluding a body having a distal end, a proximal end, and an innercavity, the inner cavity including a top portion, a middle portionhaving gears, and a bottom portion, a plug including a top end housedwithin the top portion of the inner cavity and a bottom end coupled tothe top end, the bottom end extending between the middle and bottomportions of the inner cavity, a first portion housed within the bottomportion of the inner cavity and disposed on the bottom end of the plug,the first portion having gears in engagement with gears of the innercavity middle portion, a second portion housed within the inner cavitybottom and disposed on the bottom end of the plug, and a spring locatedbetween the first and second portions, the spring received within agroove of the second portion, wherein the proximal end of the innermember is housed within a channel of the plug; an anchor assemblycoupled to the shaft, the anchor assembly comprising an anchor defininga cavity, a transverse through hole extending through the anchor, and aninsertion member housed within the cavity, the outer member prongsdisposed within grooves of the anchor and the inner member prongs inengagement with the inner member; and a suture threader releasablycoupled to the outer member, the threader comprising a clip and a suturecoupled to the clip to form a loop, a portion of the loop housed withinthe through hole of the anchor.
 2. The surgical system of claim 1wherein the outer member is shorter than the inner member.